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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Ultimaster Tansei Sirolimus eluting… — 54 UDI-DI variants, MDR

MD Atlas
TERUMO EUROPE N.V.

Data from EUDAMED, last updated May 30, 2026

Ultimaster Tansei Sirolimus eluting coronary stent system

5413206UMTCS

54 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class III

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: TERUMO EUROPE N.V.

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Device characteristics

ImplantableIncorporates a medicinal product

Legacy certificates

Certificate number: 13090GB450250128
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: DNV MEDCERT GmbH (0482)
Validity: Jan 28, 2025 → Jan 27, 2030

Identity & classification

Basic UDI-DI: 5413206UMTCS
Device name: Ultimaster Tansei Sirolimus eluting coronary stent system
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: May 21, 2026

Manufacturer & authorised representative

Manufacturer

Name: TERUMO EUROPE N.V.
SRN: BE-MF-000001434
Country: Belgium
Email: EUDAMED_TE@terumo-europe.com
Phone: +3216381211

Variants by status

UDI-DI variants

54 UDI-DI variants

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Applied filters

basicUdiUlid01KS4NAS8QKXWSES5VZTZQ1QQ8

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

DE-RQ4033KSM05413206222094
DE-RQ2215KSM05413206221059
DE-RQ4021KSM05413206222032
DE-RQ2221KSM05413206221097

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